Kornimate/medical-research-clean huggingface dataset:
noninvasive modulation of chronic neuropathic pain

Conditions: Neuropathic Pain; Chronic Pain

Summary: this study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. the target will be validated using magnetic resonance imaging. the stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. a well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. the level of pain will be evaluated using the numerical rating scale (nsr-11) and the patient-reported outcomes measurement information system (promis) numerical rating scales of pain.


Eligibility criteria:
inclusion criteria: * primary diagnosis of chronic pain * moderate-to-severe chronic pain lasting at least 2 months * stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study * for females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study * capacity to provide informed consent; provision of a signed and dated consent form exclusion criteria: * poorly managed general medical condition * pregnant or breast feeding * implanted device in the back * lifetime history of a serious suicide attempt * clinically inappropriate for participation in the study as determined by the study team
fistula-associated anal adenocarcinoma

Conditions: Rectal Cancer

Summary: the fistula-associated anal adenocarcinoma is rare in patients suffering from anal fistulas. there is only little data available for this patient collective making characterization and management of this disease difficult. late diagnosis and advanced tumor stage at diagnosis result in poor clinical outcome. it is the purpose of this study to evaluate patients clinically diagnosed with a faac and to further perform a histopathological characterization of the available tumor specimen.

all patients receiving surgery for an anal fistula in the years 1999 to 2019 at a tertiary university referral hospital were included in the analysis. a retrospective review of patients' charts was performed. patients suffering from faac were eligible for histopathological analysis including immunohistochemistry and molecular profiling.

Eligibility criteria:
inclusion criteria: * anal fistula exclusion criteria: * previous cancer of the anal canal
study of effect of csj117 on symptoms, pharmacodynamics and safety in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a phase 2 study in patients with chronic obstructive pulmonary disease (copd) to assess the efficacy, pharmacodynamics (pd), pharmacokinetics (pk), and safety of two dose levels of csj117 in comparison to placebo. for this, the impact of csj117 on disease symptom burden and lung function will be explored.

this is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group, multicenter study with two fixed-dose levels of csj117 (4 mg, 8 mg) administered once-daily via oral inhalation over 12 weeks in participants with copd, prone for exacerbations and symptomatic at baseline despite background maintenance triple therapy (inhaled corticosteroids/long acting beta-2 agonist/long acting muscarinic antagonist (ics/laba/lama) combination, standard of care in this population) for at least three months prior to screening. the study will include: * screening period of up to 2 weeks to assess eligibility. * run-in period of 4 weeks where participants will be placed on fixed-dose triple background therapy (ics/laba/lama) that will be used until the patient's last study treatment. * treatment period of 12 weeks. participants will be stratified by eosinophil levels and then randomized 1:1:1 to either 4 mg csj117, 8 mg csj117, or placebo. * follow-up period of 55 days following the last dose of study drug. the primary objective of the study is to assess the effect of csj117 on disease/symptom burden after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * male and female copd patients aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure * current or ex-smokers who have a smoking history of at least 10 pack years * patients who have been treated with a triple combination of laba/lama/ics for the last 3 months prior to screening * patients with a documented diagnosis of copd for at least 1 year prior to screening visit exclusion criteria: * patients with a past or current medical history of asthma * patients who have had a copd exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment. * use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations * pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation * patients with a body mass index (bmi) of more than 40 kg/m2 other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease copd csj117
scp® observational study of the knee

Conditions: Bone Marrow Edema

Summary: post market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the subchondroplasty (scp) procedure in the knee in a standard clinical setting. outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

this is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of accufill during the subchondroplasty procedure. enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion (bml) in the knee. demographics, medical history and medications will recorded at the time of enrollment. surgical details including the scp procedure, concomitant surgical procedures and intraoperative safety events will be recorded. subjects will complete patient reported outcomes measures pre-operatively including the visual analog scale (vas) for knee pain, international knee documentation committee subject knee (ikdc) form and the veterans rand 12 (vr-12) item health survey. these measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. screening for adverse events and revision surgeries will occur throughout the study. target enrollment is 1000 subjects at up to 30 clinical sites. subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the subchondroplasty site.

Eligibility criteria:
inclusion criteria: 1. surgeon considers patient appropriate for scp procedure. 2. patient has agreed to undergo the scp procedure or has already undergone the procedure. 3. subject is willing and able to sign a written consent form. 4. the subject has the mental capacity and the willingness to contribute follow-up outcome data. 5. patient is willing and able to complete outcome forms in person or by phone, email or regular mail. exclusion criteria: 1. patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the pros in the protocol.

Keywords: subchondroplasty bone marrow lesion arthroscopy bone substitute material accufill subchondral bone defect
18f-fet pet/ct in the management of glioma

Conditions: Glioma

Summary: o-(2-\[18f\]-fluoroethyl)-l-tyrosine (fet) is a tracer for positron emission tomography (pet). the response assessment in neuro-oncology (rano) working group has officially recommended 18f-fet pet in the management of patients with brain glioma. recently, the utility of 18f-fet pet in the diagnosis of fresh and residual gliomas has been reported by several investigators. but clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18f-fet pet has been widely used in clinical studies or routine service in europe, america, mainland china, or japan. however, 18f-fet pet is still not available in taiwan. in this context, the investigator propose this study to explore the role of multiparametric 18f-fet pet imaging for glioma in taiwan, with the emphasis in radiomics analysis.

study background: o-(2-\[18f\]-fluoroethyl)-l-tyrosine (fet) is a tracer for positron emission tomography (pet). the response assessment in neuro-oncology (rano) working group has officially recommended 18f-fet pet in the management of patients with brain glioma. recently, the utility of 18f-fet pet in the diagnosis of fresh and residual gliomas has been reported by several investigators. but clinical usefulness of radiomics parameters has not been explored thoroughly in glioma patients. 18f-fet pet has been widely used in clinical studies or routine service in europe, america, mainland china, or japan. however, 18f-fet pet is still not available in taiwan. in this context, the investigator propose this study to explore the role of multiparametric 18f-fet pet imaging for glioma in taiwan. materials and methods: 1. during the pre-treatment work-up, the study participants undergo an 18f-fet pet/ct scan. in addition, other routine examinations, including mri with and without contrast enhancement, are performed. 2. after a definitive diagnosis of primary/recurrent glioma is confirmed, subjects begin treatment (surgery, radiation therapy, chemotherapy, etc.). within 3 to 6 months after completing treatment, the study subjects undergo a second 18f-fet pet/ct scan for response evaluation, along with a follow-up mri.

Eligibility criteria:
inclusion criteria: 1. patients with primary or recurrent brain tumors confirmed by pathological examination or imaging studies. 2. the ability to provide written informed consent and receive the scheduled scan. exclusion criteria: 1. woman with pregnancy or during lactation. 2. unsuitable for pet scans, such as those with claustrophobia or inability to lie flat. 3. unable to sign the informed consent form. 4. patients with a second primary tumor.

Keywords: glioma, 18f-fet, pet
efficacy and safety study of fentanyl transdermal patch for treatment of chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch durogesic® d-trans for treatment of chronic pain in participants with chronic non-cancer pain.

this trial is a phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (tts) durogesic® d-trans in patients with non-cancer pain. the patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). the study will be conducted for 12 weeks. the efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. all participants will use the patch at least once during the study. the drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. the overall safety will be assessed based on the adverse events reporting.

Eligibility criteria:
inclusion criteria: * spine related and extremity pain lasting for 3 months or longer * pain with numeric rating scale (nrs) at 4 or higher in the past 72 hours * good overall health condition based on the medical history and clinical laboratory tests * participants using appropriate contraception in case of childbearing potential during the study period. exclusion criteria: * history of hypersensitive reaction to narcotic analgesics * history of narcotic abuse * serious psychotic disorder * unable to use transdermal analgesics due to a dermatological condition * history of co2 retention (e.g., chronic obstructive pulmonary disease) * surgery in the area with pain within 7 days prior to initiation of the clinical study.

Keywords: chronic pain fentanyl-tts fentanyl patch transdermal non-cancer pain
crossover trial of ad182 and ad504 in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of ad182 and ad504 versus placebo in patients with obstructive sleep apnea.

the study is designed to examine the efficacy and safety of ad182 to treat obstructive sleep apnea. the study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (psg) testing with dosing of one of the following 3 treatments: ad182, ad504, or placebo. participants will return 1 week after their final crossover psg for an end of study (eos) visit.

Eligibility criteria:
inclusion criteria: * male or female between 25 and 65 years of age, inclusive, at the time of the screening visit * ahi 10 to 55 events/h if meets other psg criteria exclusion criteria: * history of narcolepsy. * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. a medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication * cpap should not be used for at least 2 weeks prior to first study psg * history of using oral or nasal devices for the treatment of osa may enroll as long as the devices are not used during participation in the study.
cross-over study to evaluate the effect on trough forced expiratory volume in one second (fev1) after 4 weeks treatment with chf 5188 pmdi qd in adult patients with persistent asthma

Conditions: Asthma

Summary: cross-over study to evaluate the effect on trough fev1 after 4 weeks treatment with chf5188 pmdi qd in adult patients with persistent asthma

a randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough fev1 after 4 weeks treatment with chf5188 pmdi qd in adult patients with moderate or severe persistent asthma

Eligibility criteria:
inclusion criteria: * moderate or severe asthma partly controlled with ics or ics/laba * fev1 ≥ 60% and ≤ 90% of predicted for the patient normal value exclusion criteria: * diagnosis of copd * history or current evidence of significant cardiovascular disease * uncontrolled concomitant disease
daily practice treatment and influence of visanne on the patient assessment of quality of life

Conditions: Endometriosis

Summary: the study aims to collect data on the influence of a treatment with visanne (dienogest 2mg/d) on the endometriosis related quality of life. these data will be collected using a special patient questionnaire (endometriosis health profile 5, ehp-5). the study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. in addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.


Eligibility criteria:
inclusion criteria: * female patients older than 18 years of age * clinical or laparoscopic diagnosis of endometriosis * having endometriosis related pain as leading symptom * decision taken by physician to prescribe visanne * signed informed consent form exclusion criteria: * contraindications listed in the local summary of product characteristics (spc) have to be considered.

Keywords: non-interventional study endometriosis, quality of life
sero-prevalence of anti-pertussis antibodies and disease awareness among spanish healthcare professionals

Conditions: Pertussis

Summary: this study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in spain.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the subject. * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * male and female healthcare professionals aged ≥18 years from selected hospitals. * healthcare professionals in frequent contact with patients in the hospitals. * agreeing for collection of a blood sample for the study. exclusion criteria: • medical students working as healthcare professionals.

Keywords: pertussis antibodies bordetella pertussis sero-prevalence healthcare professionals (hcp) spain
the community united to challenge asthma

Conditions: Asthma

Summary: this study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education in high-risk puerto rican children in elementary school. the primary outcomes are asthma medication adherence and trigger reduction.


Eligibility criteria:
inclusion criteria: * puerto rican * in elementary school * diagnosed with asthma exclusion criteria: * not in school * mild intermittent asthma * well controlled asthma

Keywords: pediatric asthma
cognitive and physical functions in patients with transient ischemic attack. a randomized controlled trial of physical activity on prescription up to one year after the event

Conditions: Ischemic Attack, Transient

Summary: the purpose of this study is to determine whether physical activation on prescription can help patients with tia to become more physically active. one group will receives physical activation on prescription (pap)and the other group will receives usual care. and to identify if persons with tia presents with cognitive impairments.

transient ischemic attack (tia) is a transient episode of neurologic dysfunction caused by ischemia, i.e. loss of blood flow. the symptoms of a tia typically resolve within 24 hours. attacks lasting more than 30 minutes are unusual. tias and strokes present with the same symptoms such as sudden weakness, numbness, sudden dimming or loss of vision, aphasia, slurred speech, facial palsy and mental impairments. subtle problems with cognitive functions and fatigue may not always be addressed before discharge. however, even subtle mental impairments are important to identify, given the problems they might pose.

Eligibility criteria:
inclusion criteria: * understand swedish language (also in and writing), living in norrtälje community, * to participate in the assessment of cognitive function: no known cognitive impairments before the tia event and history of stroke. exclusion criteria: * presence of contraindications to exercise, and no history of stroke

Keywords: walking capacity mental fatigue quality of life cognition motor activity exercise
a comparison of post phacoemulsification aqueous flare in patients using ketorolac 0.45% 2 times daily (bid) and bromfenac 0.09% 2 times daily (bid)

Conditions: Post Operative Anterior Chamber Inflammation (Flare)

Summary: approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% bid or bromfenac 0.09% bid. patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. kowa flare measurements will be performed at postoperative day one and postoperative day 14. the amount of anterior chamber inflammation (flare) will be objectively measured.


Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older * scheduled for cataract surgery by phacoemulsification * subject must be willing to comply with all study requirements and be willing to give informed consent exclusion criteria: * any subject that has a history of uveitis or active iritis * subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months * no ocular use of prostaglandins within 2 weeks of surgery * use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (nsaids) or immunosuppressants within 14 days prior to surgery * contraindications to nsaids * active ocular infection
vitamin d supplementation in childhood atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the goal of this clinical trial is to investigate the therapeutic role of vitamin d supplementation in a subset of patients with atopic dermatitis (ad): children with disease onset or worsening in the winter. the investigators hypothesis is that (1) vitamin d supplementation in patients with either wintertime onset or exacerbation of ad will improve eczema area and severity index (easi) scores, and (2) vitamin d supplementation will improve the investigator's global assessment.


Eligibility criteria:
inclusion criteria: * age 2-17 years * ad rated 10-72 by easi scale * wintertime onset or exacerbation of ad exclusion criteria: * active skin infection * history of summertime onset or exacerbation of ad * history of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies) * medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month * parathyroid disease * acute or chronic renal disease * hypercalcemia or hypocalcemia * thyroid disease * history of osteomalacia or paget's disease of bone * history of malabsorption (eg cystic fibrosis) * planned trip to sunny climate during the one-month study

Keywords: vitamin d atopic dermatitis eczema winter
study of titanium-coated peek cages for degenerative disc disease

Conditions: Spinal Fusion; Cervical Vertebral Fusion

Summary: prospective follow-up study of cespace xp coated peek cages for the treatment of degenerative cervical disc disease

anterior cervical discectomy and fusion (acdf) has been accepted as the standard procedure for the treatment of myelopathy and radiculopathy in the cervical spine. a tricortical iliac crest bone graft is the traditional inter-body fusion material that can show perfect bony fusion and maintain the patency of the neuroforamen. however, donor site complications were reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and chronic wound pain. currently, the titanium cage and polyetheretherketone (peek) cage are the two most common cages in clinical practice. the ideal cage should lead to a high fusion rate and prevent complications, such as subsidence and loss of correction. even though a titanium cage can provide long-term stabilization, increase lordosis, and increase foramina height compared with the iliac bone graft, some inferior clinical outcomes appeared in clinical practice. loss of correction is a major complication of subsidence that may eventually affect cervical spinal function after the operation. a modulus of elasticity close to cortical bone might contribute to advantages in stress distribution and load sharing, which can contribute to a lower subsidence rate and, thus, better clinical results, making peek cages more welcomed by surgeons. it is supposed, that in the cervical fusion procedure, a porous coating of a peek cage will lead to favourable results. therefore, the present study intends to show these results, in a larger patient cohort who received such a coated cervical cage.

Eligibility criteria:
inclusion criteria: * all consecutive patients who received a cespace xp cage between august 2013 and january 2017 exclusion criteria: * pregnancy * patient consent not signed

Keywords: cervical vertebrae postoperative complications radiography spinal fusion coating